biocompatibility & toxicology
Biocompatibility assessment of medical devices, from the drafting of the biological evaluation report (BER) to the performance of tests under Good Laboratory Practices (GLP). Performance of GLP tests for the evaluation of the toxicity of chemical products (REACH regulations, biocides and phytosanitary products).
Services offered
- Biocompatibility
- Toxicology
- Mutagenicity / Genotoxicity
- Biological and Toxicological Evaluation of Medical Devices
- Safety pharmacology in compliance with Good Laboratory Practices
- Aquatic ecotoxicity / biodegradability (partnership)
Strengths
- Customer support throughout the project
- Ability to propose customized protocols
- Room dedicated to surgery
- Tests performed in France
- Expert in regulations
Specific features
- Development of alternative tests
- Partnership with two French laboratories for physicochemical characterization
- “Speed Access” for emergency testing
Biocompatibility :
Biological Evaluation of Medical Devices
- ISO 10993-1: Drafting of the biological evaluation plan (risk management process, general classification of the product, evaluation of existing data….) and the biological evaluation report
- ISO 10993-2: Follow-up of recommendations on animal ethics
- ISO 10993-3: Evaluation of genotoxicity, carcinogenicity, reproductive and developmental toxicity
- ISO 10993-4: Evaluation of interactions with blood
- ISO 10993-5: Evaluation of cytotoxicity
- ISO 10993-6: Evaluation of local effects after implantation
- ISO 10993-9: Assessment of potential degradation
- ISO 10993-10: Sensitization
- ISO 10993-11: Systemic Toxicity / Pyrogens
- ISO 10993-12: Sample Preparation
- ISO 10993-13: Polymer Degradation
- ISO 10993-14: Ceramic Degradation
- ISO 10993-15: Degradation of Metal Medical Devices
- ISO 10993-17: Writing Toxicological Evaluation Reports
- ISO 10993-18: Chemical Characterization of Medical Devices
- ISO 10993-22: Guidelines for Nanomaterials
- ISO 10993-23: Irritation Testing
Biocompatibility Evaluation of Respiratory Gas Pathways in Healthcare Applications
- ISO 18562 -1: Evaluation and Testing within a Risk Management Process
- ISO 18562 -2: Testing for particulate matter emissions
- ISO 18562-3: Testing for emissions of volatile organic compounds (VOCs)
- ISO 18562-4: Testing for leachable substances in condensate
Toxicology:
- OECD 439, OECD 431 & OECD 435: Skin Irritation/Corrosion
- OECD 438 & 492B: Eye Irritation / Corrosion
- OECD 404: Irritation / Skin Corrosion
- OECD 405: Irritation / Eye Corrosion
- OECD 442C, 442D & 442E: Skin Sensitization (Subcontracted)
- OECD 406 & 442B : Skin Sensitization
- OECD 420, 423 & 425: Acute Oral Toxicity
- OECD 402: Acute Dermal Toxicity
- OECD 403 / 436: Acute Inhalation Toxicity (Subcontracting)
- OECD 474: Chromosomal Aberrations
Our premises
Martillac – Gironde
Two laboratories to 1,700 sq. m.
Professions
Regulatory Affairs :
- Regulatory Affairs Assessors
- Regulatory Affairs Assistant
Laboratories :
- Laboratory Manager
- Technical Manager
- Laboratory Coordinator
- Laboratory Technician
Support Services :
- Quality Assurance
- Maintenance and Metrology
- IT Department
- Administrative Department
- Sales Department
48 employees including 5 PhDs and 8 masters divided into 3 units and 5 departments.
Date of creation
The Phycher Bio Développement and Lemi laboratories were founded in 1997 & 1998. These two laboratories were bought up by Icare and incorporated in the Group in 2020.
